Clinical Diagnostic Solutions, Inc. Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
Brand
Clinical Diagnostic Solutions, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Part Number 1400075 (US) Part Number 1400011 (OUS) All serial numbers distributed prior to 3/21/2019
Clinical Diagnostic Solutions, Inc. is recalling Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400 due to A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspirat. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle.
Recommended Action
Per FDA guidance
Consignees notified via email and postal delivery with recall letter dated 01/02/2020. The letter identified affected product, stated reason for recall, and provided specific actions to follow. A Recall Acknowledgement Form was requested to be returned by email, postal delivery, or fax. Clinical Diagnostic Solutions Inc. is handling US consignees only. Boule Medical AB is handling OUS consignees.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026